US20110092985A1 - Finger guided suture fixation system - Google Patents

Abstract

A suture fixation system includes a suture assembly having an anchor, an introducer, and a delivery device. The introducer is attachable to a finger of a person and includes a platform attached to an exterior of the introducer and a zip line attached to the platform. The delivery device is movable along the zip line and configured to removably retain the anchor. The introducer allows the finger to identify a target landmark within a patient and the delivery device is movable along the zip line and attachable to the platform to position the anchor for insertion to the target landmark.

Description

BACKGROUND
• Intracorporeal suturing of tissue during surgery presents challenges to the surgeon in that the surgeon is called upon to manipulate one or more suturing instruments within the confines of an incision formed in the patient's body. In some cases, the surgeon will use his/her finger(s) to dissect tissue or separate tissue along tissue planes to form a space within the tissue that allows the surgeon to palpate and identify a desired target location for placement of a suture. Often, the space formed in the dissected tissue is opened until it is large enough to receive both the surgeon's finger(s) and the suturing instrument(s). The space provides access to the identified target location where it is desired to place the suture. However, the target location is often disposed inside the patient's body at an angle that is difficult to reach and can have a depth that precludes visualization of the target location. Delivering surgical instruments to the target location is challenging when the target location cannot be visualized by the surgeon.
SUMMARY
• One aspect provides a suture fixation system including a suture assembly having an anchor, an introducer, and a delivery device. The introducer is attachable to a finger of a person and includes a platform attached to an exterior of the introducer and a zip line attached to the platform. The delivery device is movable along the zip line and configured to removably retain the anchor. The introducer allows the finger to identify a target landmark within a patient and the delivery device positions the anchor for insertion to the target landmark.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better, understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.
• FIG. 1 is an exploded schematic view of one embodiment of a digital suture fixation system including an introducer and an anchor delivery device.
• FIG. 2 is a bottom view of the introducer illustrated inFIG. 1.
• FIG. 3 is a top view of the delivery device illustrated inFIG. 1.
• FIG. 4 is a cross-sectional view of the delivery device illustrated inFIG. 3.
• FIG. 5 is an end of view of the delivery device illustrated inFIG. 3.
• FIG. 6A is a side view of a finger wearing the introducer illustrated inFIG. 1.
• FIG. 6B is a side view of the delivery device illustrated inFIG. 3 shuttled along a zip line to the introducer illustrated inFIGS. 1 and 2.
• FIG. 6C is a side view of the system illustrated inFIG. 1 employed to deliver an anchor to tissue of a patient according to one embodiment.
• FIG. 6D is a schematic view of a suture line trailing away from the anchor that has been fixed into the tissue of the patient.
• FIG. 7 is an exploded perspective view of a digital suture fixation system including an introducer and an anchor delivery device according to one embodiment.
• FIG. 8A is an exploded side view of the system illustrated inFIG. 7.
• FIG. 8B is a schematic exploded view of a cable engaging with an anchor assembly of the system illustrated inFIG. 8A according to one embodiment.
• FIG. 9A is a side view of a finger wearing the system illustrated inFIG. 7.
• FIG. 9B is a side view of the delivery device illustrated inFIG. 7 delivered to a landmark inside of the patient's body.
• FIG. 9C is a side view of the system illustrated inFIG. 7 employed to deliver an anchor to the landmark inside of the patient's body.
• FIG. 9D is a side schematic view of a telescoping anchor housing.
• FIG. 10 is a perspective view of an optional position marker configured to be employed with the system illustrated inFIG. 7 according to one embodiment.
• FIG. 11 is a side plan view of a digital suture fixation system including a delivery device attached to an introducer band according to one embodiment.
• FIGS. 12A-12C are schematic cross-sectional views of the digital suture fixation system illustrated inFIG. 11 employed to throw a needle through tissue according to one embodiment.
• FIG. 13 is a perspective view of the introducer band illustrated inFIG. 11.
• FIG. 14 is a perspective view of another embodiment of an introducer band.
• FIG. 15 is a perspective view of another embodiment of an introducer band attached to the delivery device illustrated inFIG. 11.
• FIG. 16 is a perspective view of another embodiment of an introducer band attached to the delivery device illustrated inFIG. 11.
• FIG. 17 is a perspective view of another embodiment of an introducer band attached to the delivery device illustrated inFIG. 11.
DETAILED DESCRIPTION
• In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
• It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise.
• Tissue includes soft tissue, which includes dermal tissue, sub-dermal tissue, ligaments, tendons, or membranes. As employed in this specification, the term “tissue” does not include bone.
• A digital suture fixation system is a system that allows suture line to be thrown through tissue and/or allows the placement of an anchor into the tissue with a hand or one or more fingers on the hand. A digital suture fixation system allows for the “finger tack” fixation of suture line and/or anchors into the tissue.
• Embodiments provide a finger guided suture fixation system that includes an introducer that is configured to be donned over a finger of a surgeon to allow the finger to palpate and identify a landmark within the patient, and a delivery device configured to insert an anchor at the identified landmark. As an example, the introducer is provided with a zip line that is sized to trail proximally behind the finger to a location outside of the patient's body. The delivery device is movable along the zip line and attachable to the introducer. In this manner, the surgeon is able to locate a target site of interest with his/her finger and pass the delivery device along the zip line to the finger until it is placed at or near the target site to allow the precise placement of the anchor even without visually seeing the target site.
• In this specification, “zip line” means a conduit, such as a cable, that provides a pathway from a location exterior a patient's body to a location intracorporeal the patient's body.
• FIG. 1 is a side view of one embodiment of a digitalsuture fixation system150.System150 includes anintroducer152 that is attachable to a finger F, adelivery device154 that is attachable tointroducer152, and ananchor156 that is removably retained in thedelivery device154.
• In one embodiment,introducer152 includes afinger cot160, aplatform162 attached to an exterior surface offinger cot160, and azip line164 attached toplatform162. In one embodiment,delivery device154 includes acar170 configured to couple with and move along thezip line164 and ashaft174 that is configured to ejectanchor156 fromcar170. Thecar170 defines aport172 sized to encloseanchor156. In one embodiment,anchor156 includes abarb portion180 configured to engage with tissue and asuture line182 trailing frombarb portion180. In one embodiment, theshaft174 includes adistal end190 that is attachable to thecar170, aproximal end192 including aplunger194, and arod196 that moves into and out of theshaft174 in response to movement of theplunger194.
• System150 is adapted to deliveranchor156 to a landmark within the patient, where the landmark is not necessarily visible to the surgeon. For example, thefinger cot160 allows the finger F to identify the desired landmark, thecar170 is attachable to the platform162 (which is located near a distal end of the finger F) to ensure that theanchor156 is directed to the landmark identified by the finger F, and theshaft174 is employed to selectively eject theanchor156 into the landmark. Although the landmark inFIG. 1 is illustrated as a ligament,system150 is configured to allow the surgeon to palpate and identify any of a variety of intracorporeal landmarks.
• The systems disclosed in this specification are suited for the intracorporeal suturing of tissue during pelvic organ repair surgery, and in one embodiment are provided as sterile disposable surgical instruments that are discarded after the surgical procedure. To this end, the components of the systems are selected to be compatible with gas, steam, or radiation sterilization.
• FIG. 2 is a bottom view ofintroducer152 showingzip line164 trailing from a proximal end ofintroducer152. In one embodiment,introducer152 includes awindow200 formed in thefinger cot160 betweenplatform162 and a distal end of thefinger cot160. In one embodiment, thewindow200 allows the finger F to directly contact tissue within a patient. In one embodiment, thewindow200 allows a finger F inside of a glove (not shown) to identify a tissue landmark within a patient, where the glove is selected to provide the surgeon with a level of dexterity suited to sensing and discriminating different intracorporeal tissue landmarks. Theplatform162 includes aretainer204 that is configured to engage with the car170 (FIG. 1) to secure thecar170 to theintroducer152. In one embodiment, theretainer204 is provided as a pair of opposing substantially spherical recesses that are sized to receive spring-loaded ball bearings provided on thecar170.
• Finger cot160 is selected to be conformable to a distal end of the finger F, suitably elastic, and is suitably fabricated from plastic, metal, or combinations of plastic and metal (e.g., malleable metal thimbles covered with plastic as one example).Platform162 is attached tofinger cot160 and is suitably formed from plastic, metal, or combinations of plastic and metal.Suitable suture line182 materials include suture employed by surgeons in the treatment of pelvic organ prolapse, such as polypropylene suture, or the suture identified as Deklene, Deknatel brand suture, as available from Teleflex Medical, Mansfield, Mass., or suture available from Ethicon, a Johnson&Johnson Company, located in Somerville, N.J.
• Thezip line164 is flexible and is suitably fabricated from a polymer strand, or a braided cable coated with plastic, as examples.
• In one embodiment,introducer152 is integrated into a distal finger sleeve of a glove, which allows theintroducer152 to be more closely associated with the surgeon's hand.
• FIG. 3 is a top view ofcar170,FIG. 4 is a cross-sectional view ofcar170, andFIG. 5 is a proximal end view ofcar170. In one embodiment,car170 includes aproximal end210 opposite adistal end212, aplatform dock214 formed adjacent todistal end212, azip line channel216 extending betweenend210 anddock214, and asuture channel218 extending betweenend210 andport172. Theplatform dock214 includes alock220 configured to couple withretainer204 to securecar170 to platform162 (FIG. 2). In one embodiment, thelock220 includes spring-loaded ball bearings or another form of a biasing member configured to engage withrecesses204 formed onplatform162. Thecar170 is configured to slide along thezip line164 untillock220 engages withretainer204 to secure thecar170 to theplatform162.
• In one embodiment,threads222 are formed within a proximal end ofsuture line channel218 and are sized to receive a threadeddistal end190 of shaft174 (FIG. 1). In this manner,shaft174 is configured to be removably attached to thecar170 such that rod196 (FIG. 1) is aligned withsuture line channel218 and thebarb portion180 ofanchor156.
• FIG. 5 is a proximal end view ofcar170. In one embodiment,car170 is substantially a circular cylinder, although other shapes and sizes that accommodate the intracorporeal delivery of thecar170 into the patient, as guided by the surgeon's preferences, are also acceptable.
• FIGS. 6A-6D are side views ofsystem150 employed to insert an anchor into tissue according to one embodiment.
• FIG. 6A is a side view ofintroducer152 placed over the finger F such that the finger F is available to palpate tissue through thewindow200.
• FIG. 6B is a side view ofcar170 andshaft174 ofdelivery device154 moving along azip line164 for engagement withplatform162. It is to be understood thatshaft174 could be suitably attached tocar170 beforecar170 is engaged with thezip line164 or after thecar170 is engaged with thezip line164.
• FIG. 6C is a side view of thecar170 engaged with theplatform162 and theshaft174 connected to thecar170. In one embodiment, thebarb portion180 of theanchor156 is retained within port172 (FIG. 1) andsuture line182 trails from theproximal end210 of the car170 (FIG. 4). In this configuration, theshaft174 is connected to thecar170, and thecar170 is connected to theplatform162, where theplatform162 and thecar170 are positioned adjacent to thewindow200 and thus ready to deliver thebarb portion180 into the tissue (e.g., ligament) palpated by the finger F. In one embodiment, the surgeon uses the opposite hand (e.g., the hand to whichintroducer152 is not attached) to activate theplunger194, which drives the rod196 (FIG. 1) axially from theshaft174 to eject thebarb portion180 of theanchor156 axially from thecar170 and into the ligament, as illustrated inFIG. 6D. Although theplunger194 is illustrated as a push-activated mechanical device inFIG. 6C, other embodiments of theplunger194 provide a plunger that operates pneumatically or electro-mechanically. Other suitable activation mechanisms for movingrod196 to deliveranchor156 include pull activation, twist activation, or squeeze activation ofshaft174 to activate movement ofrod196.
• Theanchor156 is configured to penetrate tissue, including tough ligament tissue, and engage with the tissue after penetration. In one embodiment, thebarb portion180 is selectively deployed to expand from theanchor156 only after the anchor penetrates into the tissue. In one embodiment, thebarb portion180 extends laterally from theanchor156 and engages with the tissue as soon and the anchor penetrates into the tissue.
• FIG. 7 is a perspective view of another embodiment of a digitalsuture fixation system250. In one embodiment,system250 includes anintroducer252 that is attachable to a finger, adelivery device254 attached tointroducer252, and an anchor (not shown) that is removably attachable todelivery device254. In one embodiment, theintroducer252 is aband252 that is attachable to the finger and thedelivery device254 and includes ananchor housing256 attached to an exterior surface of theband252. Thedelivery device254 includes ashaft258 having adistal end260 that is configured to thread into a proximal end of theanchor housing256. Theanchor housing256 is sized to retain an anchor (or an anchor and a suture line) and theshaft258 is configured to deploy the anchor from theanchor housing256.
• FIG. 8A is a side view ofsystem250. Theanchor housing256 includes achannel270 that is sized to receiveanchor156 andsuture line182. In one embodiment,anchor housing256 has a longitudinal length between about 0.75-1.5 inches, andband252 is configured to allowhousing256 to slide/move longitudinally (laterally left and right in the orientation ofFIG. 8A). In this manner, theanchor housing256 is sized to be positioned at a base segment of the finger (behind the distal-most joint of the finger) to allow the distal end of the finger freedom of movement. Theanchor housing256 is configured to move relative to theband252 to a position adjacent to the distal end of the finger F to bring theanchor156 near the desired landmark previously identified by the surgeon's finger F.
• In one embodiment, theband252 is provided as adjustable band including a buckle or other adjustable form of attachment. Suitable materials for fabrication of theband252 include plastics, metals, or combinations of plastics and metals. In one embodiment, theanchor housing256 is molded from plastic attached to theband252. In one embodiment,shaft258 is similar to shaft174 (FIG. 1).
• FIG. 8B is an exploded schematic view ofshaft258 moved distally forward and ready for engagement withanchor156. In one embodiment,shaft258 includes anextensible post272 that is configured to extend out of adistal end260 ofshaft258 to engage with abore274 formed inanchor156. In this manner, thepost272 is configured to drive theanchor156 axially out of thechannel270 and into the tissue of the patient.
• FIGS. 9A-9C provides schematic views ofsystem250 employed to deliver an anchor into tissue.
• FIG. 9A is a schematic view of theband252 attached to the finger F in a manner that locates theanchor housing256 at the base of the finger F near the web of the thumb. The distal end of the finger F is unimpeded by theanchor housing256 and is thus free to palpate the tissue. Theshaft258 trails behind theanchor housing256 out of the patient's body for access by the other hand (e.g., the right hand in this example).
• The finger F is fully mobile (even if protected by a surgical glove) and able to palpate a desired tissue location for deployment ofanchor156. As illustrated inFIG. 9B, theanchor housing256 is movable relative to theband252 to position the distal end of the anchor housing256 (retaining the anchor156) next to the tissue landmark. In one embodiment, theshaft258 is pushed in a proximal direction to displace thehousing256 proximally forward toward the tissue.
• Theanchor housing256 is not drawn to scale. In one embodiment, it is desirable to provide theanchor housing256 in a low-profile format (e.g. a flat elliptical shape) that is configured to lay flat against the palm of a user's hand. For example, in one embodiment theanchor housing256 has a lateral cross-sectional size that is similar to the size of the diameter of theshaft258 such that theshaft258 and thehousing256 appear as a single cable.
• FIG. 9C illustratesanchor156 driven into the tissue by the post272 (FIG. 8B) of theshaft258. Thesuture line182 is optional, and if provided, trails behind theanchor156 through theanchor housing256 and behind the hand of the surgeon. In one embodiment, theshaft258 is rotated counterclockwise (one-quarter to one-half of a turn) to disengage theshaft258 from theanchor156. Thereafter, the surgeon retracts the finger F and thesystem250 from the patient leaving theanchor156 inserted into tissue and thesuture line182 trailing away from the anchor and out of the patient. Thesuture line182 is tied off to reinforce or suture the pelvic floor of the patient. Alternatively, thesuture line182 serves as a conduit into the patient's body for delivery of support mesh intracorporeally to the insertedanchor156.
• FIG. 9D is a side schematic view of atelescoping anchor housing256′. Thetelescoping anchor housing256′ has aproximal end280 that nestles against a web of the hand and adistal end282 that moves forward toward the distal end of the finger F when theshaft258 is pressed into theproximal end280 of theanchor housing256′. Theproximal end280 contacts the webbing of the hand to allow the hand to drive thedistal end282 forcefully into the tissue to ensure that theanchor156 penetrates tough tissue. Consistent with the above description, activation of theshaft258 moves thepost272 in the axial forward direction to eject theanchor156. In one embodiment,shaft258 is attached to theproximal end280 of thedelivery device256′, theshaft258 is pushed distally, and separating segments of thetelescoping delivery device256′ axially expand to driveanchor180 into the tissue.
• FIG. 10 is a perspective view of anoptional position marker290 configured for use withsystem250. In one embodiment,position marker290 includes adistal surface292, aproximal surface294, aslot296 formed between thesurfaces292,294, and ahole298 formed in theproximal surface294. In one embodiment,position marker290 is provided as a stroke-length control and twist-release locator that is configured to be tacked into position by theanchor156. For example, in one embodiment thehole298 is sized to receive the distal end of anchor housing256 (FIG. 8A) to allow accurate placement of theanchor156 into the tissue. Theposition marker290 functions to prevent inserting theanchor156 too deeply into the tissue. Theposition marker290 also functions to prevent twisting of theanchor156 after placement of theanchor156 to tissue. In one embodiment,position marker290 includes anothersuture line300 that is configured to trail out of the patient's body to a location that can be accessed by the surgeon for the subsequent delivery of support mesh into the patient to the location at whichposition marker290 has been affixed.
• Suitable materials for fabrication ofposition marker290 include plastic or radio-opaque material.
• FIG. 11 is a side plan view of a digitalsuture fixation system350 including anintroducer band352 that allows the surgeon to use a finger to precisely place adelivery device354 next to a tissue landmark. Theintroducer band352 is attachable to the finger F and asuture assembly356 is retained by ahead364 of thedelivery device354. This configuration allows the finger F to guide thehead364 of thedelivery device354 directly and precisely to an intracorporeal tissue landmark (i.e., a target) identified by the finger F. The surgeon inserts his/her finger into theband352 to guide thedelivery device354 through the dissected tissue precisely to the landmark previously identified by the finger, which positions thehead364 for delivery of thesuture assembly356 to the tissue landmark.
• Delivery device354 includes ashaft360 coupled between ahandle362 and thedelivery head364. Theintroducer band352 is attachable to thehead364. Handle362 thus defines a proximal end ofsystem350 nearest a user of thesystem350.
• With reference toFIGS. 11 and 12A, theneedle374 is stored within aproximal end portion376 of thehead364 and thesuture assembly356 is stored within adistal end portion378 of thehead364. The open space between theproximal end portion376 of thehead364 and thedistal end portion378 of thehead364 is referred to as a throat. In one embodiment, thesuture assembly356 includes asuture line380 connected to acapsule382, and thecapsule382 is retained withindistal end378 ofhead364. Theneedle374 is adapted to move across the throat from theproximal end portion376 of thehead364 to thedistal end portion378 of thehead364. Theneedle374 is shaped to frictionally engage and mate with thecapsule382, remove thecapsule382 fromdistal end378, and retract thecapsule382 into theproximal end portion376 ofhead364. In this manner, thesuture line380 is towed behind thecapsule382 and “thrown” through the tissue.
• For example, handle362 includes anactuator370 communicating with arod372 that is disposed withinshaft360. The throat formed in thehead364 is configured to be engaged over a mass of tissue. When actuator370 is activated (for example with the surgeon's free hand exterior to the patient), therod372 moves throughshaft360 to extend theneedle374 stored within theproximal end portion376 ofhead364 axially outward through tissue and toward thedistal end378 ofhead364. Thus, theneedle374 moves away from the user (who is holdinghandle362 at the proximal end of system350) and is thrust through the tissue towarddistal end378 ofsystem350. Theneedle374 ultimately grasps thecapsule382, and theneedle374 and thecapsule382 are pulled back through the channel formed in the tissue by theneedle374. Retraction of theneedle374 pulls thesuture line380 through the tissue, to “throw” the suture line through the tissue.
• FIGS. 12A-12C are schematic cross-sectional views of digitalsuture fixation system350 employed to throwneedle374 andcapsule382/suture380 through tissue.
• FIG. 12A is a schematic cross-sectional view ofneedle374 partially extending from theproximal end portion376 ofhead364 after activation of actuator370 (FIG. 11).Capsule382 is seated in a cavity formed in thedistal end378 ofhead364. It is recommended that the surgeon direct a trailing end ofsuture380 overdistal end378 ofhead364 and back toward a proximal end of shaft360 (FIG. 11) for ease of managing the suture assembly during the procedure. To this end, in one embodiment thehandle362 is provided with a reel configured to receive thesuture380. For example, in one embodiment thesuture380 is retained on a suture cartridge, and thehandle362 is provided with a spindle configured to receive and retain the suture cartridge.
• FIG. 12B is a schematic cross-sectional view ofhead364 illustrating theneedle374 moved across the throat ofhead364 and engaged withcapsule382. It is to be understood that the throat would typically be placed over a mass of tissue that the surgeon desires to suture. Theneedle374 is reversible and configured to retractcapsule382 back in a proximal direction into the needle exit port of theproximal end portion376 ofhead364.
• FIG. 12C is a schematic view ofneedle374 and thecapsule382 partially retracted into theproximal end portion376 ofhead364. Theneedle374 is retracted until thecapsule382 is parked inside the needle exit port of theproximal end portion376 ofhead364 and thesuture380 extends across the throat ofhead364.
• System350 is suited for the intracorporeal suturing of tissue during pelvic organ repair surgery, and in one embodiment is provided as a sterile disposable surgical instrument that is discarded after the surgical procedure. To this end, the components ofsystem350 are selected to be compatible with gas, steam, or radiation sterilization.
• FIG. 13 is a perspective view of theintroducer band352. In one embodiment, theintroducer band352 is a discontinuous band defined by afirst ring segment390 separated from asecond ring segment392 by aspace394 and includes aflange396 that is configured to be removably attached to thehead364 of delivery device354 (FIG. 11). In one embodiment, the first andsecond ring segments390,392 are curved to define a substantially circular band sized to flexibly fit around a finger of a surgeon. Thespace394 permits thering segments390,392 to flex and adjust around differently sized fingers. Theintroducer band352 is adapted to be placed over a finger of the surgeon to direct thehead364 of thedelivery device354 to a tissue landmark. The distal end of the finger of the surgeon is unencumbered and free to palpate tissue of the patient while theband352 holds thedelivery device354 at the ready for placement ofsuture380 andcapsule382.
• In one embodiment, theintroducer band352 is molded from plastic. In one embodiment, theintroducer band352 includes a metal core (such as aluminum) having a plastic (such as silicone) molded over the metal core.
• FIG. 14 is a perspective view of another embodiment of anintroducer band402.FIG. 14 is oriented such that the view is directed to the pad P of the finger F, and an outside surface of the index finger F is oriented in the up direction. That is to say,FIG. 14 is a depiction of a pad of a left hand index finger.
• In one embodiment, theintroducer band402 includes abase404, a first pair ofarms406 that are configured to wrap a portion of the way around the finger F, asingle arm408 that is configured to wrap a portion of the way around the finger F in a direction opposite the first pair ofarms406, and ametal interface410 attached to thebase404. In one embodiment, themetal interface410 is a ferrous metal that is configured to magnetically couple with a magnet that is provided inside of thehead364 of the delivery device354 (FIG. 11).
• Theintroducer band402 is malleable and configured to conform around a finger of the surgeon. In one example, theintroducer band402 is fabricated from a malleable sheet of metal that is over molded with a plastic coating, such as a core of 3003 series aluminum that is over molded with silicone.
• When theintroducer band402 is donned, the pad P of the finger F is exposed and available for palpating tissue to locate a desired landmark within a patient. Thereafter, the surgeon magnetically attaches thehead364 of the delivery device354 (FIG. 11) to themetal interface410 of theintroducer band402, and using the finger F, digitally delivers thehead364 to the landmark.
• FIG. 15 is a perspective view of another embodiment of anintroducer band422 attached to thehead364 of the delivery device354 (FIG. 11). In one embodiment, theintroducer band422 includes abelt424 having abuckle end426, afree end428, and abuckle430 configured to selectively engage thefree end428 of thebelt424. In one embodiment, anexterior surface432 of thebelt424 includes engagement recesses434 that allow thebuckle430 to adjustably engage thebelt424 around a finger of the user. In one embodiment, thebelt424 is fabricated from plastic and thebuckle430 moves about apin436.
• During use, the surgeon will use a finger to palpate a desired landmark within a patient prior to donning theintroducer band422. Thereafter, theband422 is attached to the finger to allow the finger to guide thehead364 of the delivery device354 (FIG. 11) directly to the identified landmark. In one embodiment, theintroducer band422 is attached to the surgeon's finger and the surgeon subsequently uses the finger to palpate a desired landmark within a patient.
• FIG. 16 is a perspective view of another embodiment of anintroducer band442 attached to thehead364 of the delivery device354 (FIG. 11). In one embodiment, theintroducer band442 includes ashell444 that is sized to receive thehead364 and abelt446 that slides between twoopposed flanges448,450 to form afinger slot451. In one embodiment, abelt stop452 is provided that includes apost454 that slides within anangled slot456 to allow the selective adjustment of thebelt446 around the finger F. Thebelt stop452 is configured to prevent theband446 from sliding through theflange450, which would undesirably result in thefinger slot451 expanding after it is had been sized to fit around the finger of the surgeon.
• FIG. 17 is a perspective view of another embodiment of anintroducer band462 attached to thehead364 of the delivery device354 (FIG. 11). In one embodiment, theintroducer band462 is integral with thehead364. Anadjustable finger slot463 is provided by abelt464 that is formed to extend from a base of thedelivery head364 and terminate at anadjustable engagement slide466. In one embodiment, thebelt464 includes apressure platform468 that allows thebelt464 to be adjusted by movement of oneend470 of thebelt464 relative to theengagement slide466. In one embodiment, theengagement slide466 is provided with a saw tooth pattern that is configured to mesh with saw teeth provided on theend470 of thebelt464 to provide an adjustable and removable locking mechanism. Alternatively, theengagement slide466 is provided with a hook-and-loop form of adjustable attachment. In one embodiment, theintroducer band462 is integrally formed as a complement of thedelivery head364.
• Embodiments of digital suture fixation systems have been described that include a digital introducer that is attachable to a finger to guide an anchor delivery device intracorporeally to a patient. The introducer is attachable to the finger in one of a variety of approaches, include attachment bands, magnetic attachment mechanisms, finger cots, attachment strands such as zip tie style strands, etc. The introducer is configured to allow the finger to palpate and identify a landmark within a patient and the delivery device is configured to insert an anchor or a suture attached to an anchor or capsule into the landmark. Thus, accurate placement of the anchor/suture is provided even if the landmark is not visible to the surgeon.
• Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.

Claims (14)

1. A suture fixation system comprising:

a suture assembly comprising an anchor;

an introducer that is attachable to a finger of a person, the introducer comprising a platform attached to an exterior of the introducer and a zip line attached to the platform; and

a delivery device movable along the zip line and configured to removably retain the anchor;

wherein the introducer allows the finger to identify a target landmark within a patient and the delivery device is movable along the zip line and attachable to the platform to position the anchor for insertion to the target landmark.

2. The suture fixation system ofclaim 1, wherein the anchor is a tissue penetrating anchor comprising a tissue penetrating barb extending from a flange and the suture assembly comprises a suture line connected to the flange.

3. The suture fixation system ofclaim 1, wherein the target landmark is an intracorporeal landmark and the zip line extends from the intracorporeal landmark to a location outside of the patient.

4. The suture fixation system ofclaim 1, wherein the delivery device comprises a car defining a channel that is configured to couple to the zip line.

5. The suture fixation system ofclaim 4, wherein the car defines a port sized to enclose the anchor.

6. The suture fixation system ofclaim 5, wherein the delivery device comprises a cable having a distal end attachable to the car and a rod disposed in the cable.

7. The suture fixation system ofclaim 6, wherein the rod is movable within the cable to axially eject the anchor from the port.

8. The suture fixation system ofclaim 1, wherein the introducer comprises a finger cot attachable to a distal tip of the finger, the platform attached to an exterior of the finger cot.

9. The suture fixation system ofclaim 8, wherein the finger cot defines a window sized to allow the distal tip of the finger to touch the target landmark, the platform located proximal the window.

10. A digital suture fixation system comprising:

a suture assembly comprising an anchor;

an introducer that is attachable to a finger of a person and configured to allow a distal tip of the finger to identify an intracorporeal landmark within a patient;

a delivery device separable from the introducer that is configured to retain the anchor;

means for guiding the delivery device from a location exterior the patient to the introducer disposed at the intracorporeal landmark; and

means for securing the delivery device to the introducer disposed at the intracorporeal landmark.

11. The digital suture fixation system ofclaim 10, wherein the introducer comprises a zip line that is configured to trail from the introducer placed at the intracorporeal landmark to the location exterior the patient.

12. The digital suture fixation system ofclaim 11, wherein the delivery device is a car that is movable along the zip line from the location exterior the patient to a platform attached to the introducer.

13. The digital suture fixation system ofclaim 10, further comprising:

means for ejecting the anchor from the delivery device.

14-21. (canceled)

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